老年特应性皮炎患者使用度普利尤单抗治疗的药物留存率及安全性回顾性队列分析

Drug survival rate and safety of dupilumab in the treatment of atopic dermatitis in elderly patients:a retrospective cohort analysis

目的分析老年特应性皮炎患者使用度普利尤单抗的药物留存率及安全性。方法回顾性分析2021年5月至2023年5月在中国医学科学院皮肤病医院住院并使用度普利尤单抗治疗的特应性皮炎患者资料。筛选年龄≥60岁的老年特应性皮炎患者进入观察组,按照疾病严重程度匹配年龄<60岁的患者进入对照组。从开始用药随访至用药后24周,比较两组患者度普利尤单抗的药物留存率和安全性。使用Kaplan-Meier生存曲线分析药物留存率,两组患者药物留存率的差异性比较采用log-rank检验,采用卡方检验比较两组的停药原因。结果观察组和对照组各纳入特应性皮炎患者45例,两组患者疾病严重程度相匹配。用药后24周,对照组度普利尤单抗的药物留存率为57.8%(26/45),观察组为37.8%(17/45),两组差异有统计学意义(P=0.030)。观察组45例中,用药满24周的17例患者中4例为结节性痒疹表型,而用药不满24周的28例患者无此表型,两组间结节性痒疹比例差异有统计学意义(P=0.007)。观察组28例停药的主要原因为疗效不佳8例(28.6%),经济原因5例(17.9%)和症状持续缓解4例(14.3%),不良反应为结膜炎(2例)和可疑全身过敏反应(3例);对照组19例停药的主要原因为疗效不佳7例(36.8%)和症状持续缓解6例(31.6%),不良反应为注射部位反应(1例);两组患者停药原因差异无统计学意义(P>0.05)。结论度普利尤单抗在老年特应性皮炎患者中总体安全性好,但其药物留存率低于年轻患者。

Objective To analyze the drug survival rate and safety of dupilumab in the treatment of atopic dermatitis(AD)in elderly patients.Methods Clinical data were collected from patients diagnosed with AD and treated with dupilumab at the Hospital of Dermatology,Chinese Academy of Medical Sciences from May 2021 to May 2023,and were retrospectively analyzed.The patients aged≥60 years were selected as a study group,and disease severity-matched patients aged<60 years served as a control group.Follow-up was conducted from the start of treatment until 24 weeks after the start of treatment.Drug survival rate and safety were analyzed and compared between the two groups.Drug survival rate was determined through Kaplan-Meier survival analysis;differences in drug survival rate between the two groups were analyzed using the log-rank test;chi-square test was used to compare the reasons for treatment discontinuation between the two groups.Results The study group and the control group each included 45 patients with AD,and the disease severity of patients in the study group was matched with that in the control group.At 24 weeks after the start of treatment,there was a significant difference in the overall drug survival rate of dupilumab between the study group(37.8%,17/45)and the control group(57.8%,26/45;P=0.030).Among the 45 elderly patients with AD in the study group,a significant difference was observed in the proportion of patients with nodular prurigo phenotype between the patients who completed the 24-week treatment(4/17)and those who did not complete(0,P=0.007).Main reasons for dupilumab withdrawal in the 28 patients in the study group were poor response(8/28,28.6%),followed by unaffordability(5/28,17.9%)and persistent clinical remission(4/28,14.3%),and the adverse reactions included conjunctivitis(2 cases)and suspected systemic anaphylaxis(3 cases);the main reasons for dupilumab discontinuation in 19 patients in the control group were poor response(7/19,36.8%)and persistent clinical remission(6/19,31.6%),and the adverse reaction was injection site reaction in 1 case;there was no significant difference in the composition of reasons for drug withdrawal between the two groups.Conclusion Dupilumab generally exhibited good safety in elderly patients with AD,but its drug survival rate was lower than that in the younger patients.